A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967, to Evaluate the Effect of LY4065967 on the Pharmacokinetics of Rosuvastatin in Healthy Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin
研究概览
简要总结
The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Part A and B-Double-blinded Part A3 and D-Open-label
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
- •Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)
- •Have a body weight of:
- •≥ 40 kilograms (kg) for individuals assigned female at birth
- •≥ 50 kg for individuals assigned male at birth
排除标准
- •Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation
- •Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study
- •Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies.
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •Show evidence of syphilis or have a positive syphilis test.
- •Have an abnormal blood pressure (supine) as determined by the investigator
- •Are pregnant or intend to become pregnant or to breastfeed during the study.
- •Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission
- •Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
- •Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes
- •Are unwilling to comply with the dietary restrictions required for this study
研究组 & 干预措施
Placebo Part B
Placebo administered orally
干预措施: Placebo (Drug)
LY4065967 and Rosuvastatin Part D
LY4065967 and Rosuvastatin administered orally
干预措施: LY4065967 (Drug)
LY4065967 and Rosuvastatin Part D
LY4065967 and Rosuvastatin administered orally
干预措施: Rosuvastatin (Drug)
LY4065967 Part A
A single dose of LY4065967 administered orally
干预措施: LY4065967 (Drug)
Placebo Part A
Placebo administered orally
干预措施: Placebo (Drug)
LY4065967 Part B
Multiple doses of LY4065967 administered orally
干预措施: LY4065967 (Drug)
结局指标
主要结局
Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin
时间窗: Predose on Day 1 Through 72 Hours Post-Dose
Part D: PK: Cmax of Rosuvastatin
Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration
时间窗: Baseline to 7 Days
Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration
时间窗: Baseline to 12 Days
Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin
时间窗: Predose on Day 1 Through 72 Hours Post-Dose
Part D: PK: AUC of Rosuvastatin
次要结局
- Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967(Predose on Day 1 Through 48 Hours Post-Dose)
- Part B: PK: Cmax of LY4065967(Predose on Day 1 Through Day 9)
- Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967(Predose on Day 1 Through 48 Hours Post-Dose)
- Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967(Day 5 Through Day 11)
- Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967(Day 5 Through Day 11)